title: Impact of added fluvastatin to standard-of-care treatment on sustained virological response in naïve chronic hepatitis C Patients infected with genotypes 1 and 3.
abstract: OBJECTIVE
  The combination of pegylated interferon-α and ribavirin is a standard-of-care (SOC) treatment for chronic hepatitis C (CHC), and it achieves a sustained virological response (SVR) in 41-52% of genotype 1 and in 73-79% of genotype 3 patients. In a few clinical trials, the combination of fluvastatin and SOC increased the SVR in genotype 1 patients.
  
  
  METHODS
  This prospective study enrolled 179 naïve CHC patients. In the fluvastatin group patients received the combination of SOC and fluvastatin 80 mg daily; historical controls matching the study group in genotype, age and gender were treated with the SOC treatment only.
  
  
  RESULTS
  On-treatment viral responses as well as the SVR did not differ significantly between the two groups, except for the genotype 1 patients with a high viral load presenting a significantly higher SVR rate in the fluvastatin group (75%) compared to the control group (41%; p = 0.024). Multivariate logistic regression identified hepatitis C virus (HCV) genotype 3 infection (p < 0.001), age ≤40 years (p < 0.001), liver steatosis <5% (p < 0.01) and low viral load (p < 0.001) as independent predictors of an SVR.
  
  
  CONCLUSIONS
  A combination of fluvastatin and SOC significantly improved the SVR in naïve CHC patients infected with HCV genotype 1 and high viral load, but it did not improve the SVR in patients infected with HCV genotype 3.
authors.affiliation: Department of Infectious Diseases and Febrile Conditions, General Hospital Celje, Celje, Slovenia.
authors.forename: Tanja
authors.initials: T
authors.lastname: Selic Kurincic
authors.forename: Gorazd
authors.initials: G
authors.lastname: Lesnicar
authors.forename: Mario
authors.initials: M
authors.lastname: Poljak
authors.forename: Jelka
authors.initials: J
authors.lastname: Meglic Volkar
authors.forename: Mojca
authors.initials: M
authors.lastname: Rajter
authors.forename: Janja
authors.initials: J
authors.lastname: Prah
authors.forename: Zvonko
authors.initials: Z
authors.lastname: Baklan
authors.forename: Tadeja
authors.initials: T
authors.lastname: Kotar
authors.forename: Mojca
authors.initials: M
authors.lastname: Maticic
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination / Q000379:methods; D005229:Fatty Acids, Monounsaturated / Q000627:therapeutic use*; D005260:Female; D000077340:Fluvastatin; D005838:Genotype; D016174:Hepacivirus / Q000145:classification / Q000235:genetics / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000627:therapeutic use; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000627:therapeutic use; D012254:Ribavirin / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D005229:Fatty Acids, Monounsaturated; D007211:Indoles; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; D000077340:Fluvastatin; C417083:peginterferon alfa-2b; C100416:peginterferon alfa-2a